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Postoperative and Opioid Free Anesthesia (POFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316339
Recruitment Status : Terminated (Sponsor's decision)
First Posted : October 20, 2017
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

Since the 1960's, intraoperative administration of opioids is considered a keystone of anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anesthesia has changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids. Moreover, opioid administration consequences are neither scarce nor benign for the patient. Perioperative opioids are associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory depression, increased postoperative pain and morphine consumption, immunodepression, hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and confusion/delirium are the most frequent.

Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and postoperative opioid requirements, and subsequently, opioid-related adverse effects and to fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10 years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be achieved without opioids during anesthesia. OFA is multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and alpha-2 agonists (Dexmedetomidine).

Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid consumption during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.


Condition or disease Intervention/treatment Phase
Anesthesia Opioid-Related Disorders Drug: Dexmedetomidine Drug: Remifentanil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Opioid-free Anesthesia on Postoperative Opioid-related Adverse Events After Major or Intermediate Non-cardiac Surgery: a Multicenter Prospective Randomized Controlled Study
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : January 29, 2019
Actual Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine Drug: Dexmedetomidine
Opioid-free anesthesia

Active Comparator: Control Drug: Remifentanil
Opioid anesthesia




Primary Outcome Measures :
  1. Occurence of a severe postoperative opioid-related adverse event defined as : postoperative hypoxemia or postoperative ileus (POI) or postoperative cognitive dysfunction (POCD). [ Time Frame: Within the first 48 hours after extubation ]

    Postoperative hypoxemia is defined as an oxygen saturation (SpO2) < 95% with a need for oxygen supplementation within the first 48h after extubation; the duration of oxygen treatment will also be recorded.

    Postoperative ileus is defined as an absence of flatus or stools within the first 48h after extubation.

    Postoperative cognitive dysfunction will be evaluated using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) by a care provider (either anesthesiologist or nurse).



Secondary Outcome Measures :
  1. Number of episodes of postoperative pain (numeric rating scale ≥ 3), at rest [ Time Frame: Within 48 hours after extubation ]
  2. Opioid consumption [ Time Frame: During the 48 hours following extubation ]
  3. Time between the end of remifentanil or dexmedetomidine administration and an Aldrete score > 9 (when applicable) [ Time Frame: Within 48 hours after extubation ]
  4. Time between the end of remifentanil or dexmedetomidine administration and extubation [ Time Frame: Hour 0 = extubation ]
  5. Rate of unscheduled admission in intensive care unit [ Time Frame: Within 48 hours after extubation ]
  6. Number of postoperative nausea and vomiting (PONV) episodes [ Time Frame: During the 48 hours following extubation ]
  7. Hospital length of stay (max 28 days) defined as the number of days after extubation before first hospital discharge [ Time Frame: Day 28 ]
  8. Number of bradycardia, hypotension and hypertension events during surgery and number of rescue medications during surgery [ Time Frame: During surgery (maximum duration of 7 hours) ]
    Bradycardia is defined as the number of episodes with atropine administration. Hypotension is defined as mean arterial blood pressure < 65 mmHg. Hypertension is defined as mean arterial blood pressure > 90 mmHg.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing a scheduled major or intermediate non-cardiac surgery,
  • Benefiting from the health insurance system,
  • Having signed an informed consent.

Exclusion Criteria:

  • Pregnant or breast feeding women,
  • Allergy to dexmedetomidine or one of its excipients,
  • Allergy to one of the drugs used for anesthesia or one of their excipients,
  • Urgent surgery,
  • Intracranial surgery,
  • Transplant surgery or transplanted patients,
  • Surgery with planned regional anesthesia,
  • Outpatient surgery,
  • Atrioventricular block, intraventricular or sinoatrial block,
  • Treatment by chronic betablockers and HR < 50 bpm,
  • Heart failure with LVEF < 40%,
  • Adam-Stokes syndrome,
  • Epilepsy or seizures,
  • Uncontrolled hypotension,
  • Acute cerebral pathology,
  • Obstructive sleep apnea syndrome,
  • Severe hepatic insufficiency (Prothrombin Ratio < 15%),
  • Patients in whom the CAM-ICU cannot be performed (deaf patients for example)
  • Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316339


Locations
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France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
Beaujon Hospital
Clichy, France
Lille University Hospital
Lille, France
Metz-Thionville Hospital
Metz, France
Montpellier University Hospital
Montpellier, France
Nantes University Hospital
Nantes, France
Nimes University Hospital
Nîmes, France
Perigueux Hospital
Périgueux, France
Rennes University Hospital
Rennes, France
Saint-Brieuc Hospital
Saint-Brieuc, France
Toulouse University Hospital
Toulouse, France
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Hélène BELOEIL Rennes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03316339    
Other Study ID Numbers: 35RC16_9842_POFA
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics